Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Genogenix Llc
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·3 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex wi...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Exte...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·467 affected·Jul 30, 2025
CriticalFDA
Genogenix Llc
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW ...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3343...
Injectable Drugs·478 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·15 affected·Jul 30, 2025
High RiskFDA
Exela Pharma Sciences Llc
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Cardinal Health Inc.
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Injectable Drugs·4 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, ...
Injectable Drugs·1,550 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·83 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Bo...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 B...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Rato...
Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. A...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Cardinal Health Inc.
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Injectable Drugs·6 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·12 affected·Jul 30, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Respiratory Devices·5 affected·Jul 30, 2025
High RiskFDA
S.i.n. Implant System Ltda
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5...
Medical Implants·4,367 affected·Jul 30, 2025
High RiskFDA
Pfizer
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in ...
Oral Drugs·29 affected·Jul 29, 2025
High RiskFDA
Amerisource Health Services Llc
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-...
Oral Drugs·26,992 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the ...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Medical Devices·2,320 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all W...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025
RecallFDA
Dynamic Sports Nutrition
Anabolic Research WINN-50 (vanazolol). Dietary Supplement. 90 Capsules. UPC 8 51840-00707 6. Manafactured For: Anabolic Research, 69...
Supplements·1,566 affected·Jul 28, 2025
High RiskFDA
Vantive Us Healthcare Llc
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Medical Devices·4,772 affected·Jul 28, 2025
High RiskFDA
Vantive Us Healthcare Llc
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Medical Devices·7,432 affected·Jul 28, 2025
High RiskFDA
Ortoma Ab
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapt...
Medical Implants·261 affected·Jul 28, 2025
High RiskFDA
Dollar General Corporation
Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old...
Beverages·84,240 affected·Jul 27, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
Food·74,654 affected·Jul 25, 2025
High RiskFDA
Gelsons
Gelson's Hummus; Red Bell Pepper Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10262
Food·7,861 affected·Jul 25, 2025
CriticalFDA
Doehler North America, Inc.
Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.35OZ (10g) STRAWBERRY POUCHES 5-0.42OZ (12g) BANANA POUCHES 5-0.25 OZ (10g) AP...
Produce·21,552 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
Food·29,180 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
Food·47,065 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
Food·42,488 affected·Jul 25, 2025
High RiskFDA
Distinctive Foods Llc
Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers net wt 5.5oz. UPC 7 13733 00048 2
Bakery & Grains·1,790 affected·Jul 25, 2025
High RiskFDA
Gelsons
Gelson's Hummus; Low Sodium No Cholesterol Classic NET WT 10OZ (283g) UPC: 23631-10260
Food·7,861 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
Food·2,241 affected·Jul 25, 2025